cervical lymp node metastasis cervical metastasis
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, the subject must meet the inclusion criteria of the ICON study (NCT03134846), which are as follows: 1. Biopsy confirmed diagnosis of primary or recurrent HSCC and scheduled to undergo surgical resection as decided by the Multi-Disciplinary Head & Neck Tumor Board of the UMCG. 2. Age * 18 years 3. Written informed consent 4. Adequate potential for follow up 5. Acceptable hematologic status, kidney function, and liver function, as standard surgery protocol requires.
Exclusion criteria
Exclusion criteria: Patients will be excluded when they meet one of the exclusion criteria of the ICON study (NCT03134846), which are as follows: 1. Medical or psychiatric conditions that compromise the patient*s ability to give informed consent; 2. Concurrent uncontrolled medical conditions; 3. Received an investigational drug within 30 days prior to the dose of cetuximab-IRDye800CW; 4. Tumors at sites of which the surgeon would assess that in vivo imaging would not be feasible; 5. Had within 6 months prior to enrollment: myocardial infarction, cerebrovascular accident, uncontrolled cardiac heart failure, significant liver disease, unstable angina 6. Inadequately controlled hypertension with or without current antihypertensive medications; 7. History of infusion reactions to cetuximab or other monoclonal antibody therapies 8. Pregnant or lactating women. Documentation of a negative pregnancy test must be available for women of childbearing potential. Woman of childbearing potential are premenopausal women with intact reproductive organs and women less than two years after menopause; 9. Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females); 10. Lab values that in the opinion of the primary surgeon would prevent surgical resection; 11. Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents; 12. Magnesium, potassium and calcium deviations that might lead to cardiac rhythm (grade II or higher deviations by CTCAE); 13. Life expectancy < 12 weeks; 14. Karnofsky performance status < 70%.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quantification of the cetuximab-800CW optoacoustic signal and the tracer distribution observed by multispectral optoacoustic imaging using the MSOT Acuity Echo in vivo in patients with oral squamous cell carcinoma. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Correlation between optoacoustic signal and fluorescence intensity of cetuximab-800CW in cervical lymph nodes. - Standard histopathological assessment (i.e. hematoxylin and eosin staining) to correlate optoacoustic signal detected in vivo with histology using surgical specimens; - Histopathologic characteristics of surgical specimens related to EGFR-status and tracer distribution. | — |
Countries
Netherlands
Outcome results
None listed